The following data is part of a premarket notification filed by Ophthalmic Imaging Systems with the FDA for Winstation Retinal Imager.
| Device ID | K982689 |
| 510k Number | K982689 |
| Device Name: | WINSTATION RETINAL IMAGER |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | OPHTHALMIC IMAGING SYSTEMS 221 LATHROP WAY, SUITE I Sacramento, CA 95815 |
| Contact | Beth A Soper |
| Correspondent | Beth A Soper OPHTHALMIC IMAGING SYSTEMS 221 LATHROP WAY, SUITE I Sacramento, CA 95815 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-03 |
| Decision Date | 1998-10-23 |